Sudafed Sinus Congestion 12 Hour

Product NDC: 50090-4629
11-digit product format: 500904629
Labeler code: 50090
Product ID: 50090-4629_51527d7c-26f4-4538-928e-f3ac2bba4f84
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075153
Marketing category: ANDA
Marketing start: 2019-06-17
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 120 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		RS	1999-02-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sudafed Sinus Congestion 12 Hour
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049154	Internal RxNorm lookup
1049668	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0e4717a1-914b-466d-8bf0-d37ebc32fdb3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4629-0	Sudafed Sinus Congestion 12 Hour	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10		12
50090-4629-0	Sudafed Sinus Congestion 12 Hour	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4629-0	EA - Each	50090-4629	79a16bd9-efc7-45c0-a3ce-b26df0e9e113	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4629	SUDAFED SINUS CONGESTION 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	6	Current NDC, Legacy NDC, 2 package rows	20231026_0e4717a1-914b-466d-8bf0-d37ebc32fdb3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	HyVee Inc	8c4c786c-2b0f-4a23-a87d-effbcfe0c857	2026-06-15	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	06092347-33fe-46b8-829c-70e4ca15ecf2	2026-04-01	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
CareOne Nasal and Sinus Decongestant	PSEUDOEPHEDRINE HCL	American Sales Company	a5aa414c-a143-44c8-9759-e84c0f032fbf	2026-04-01	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
leader 12 hour nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	8b8d374c-592e-44fc-a6cc-9f9e73ef914c	2026-02-25	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
sinus and nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	e39daa3c-1901-4966-b85e-ab76d7bd1216	2026-02-17	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
equate sinus 12 hour	PSEUDOEPHEDRINE HYDROCHLORIDE	Wal-Mart Stores Inc	de65b99e-85e9-46c1-88b2-727c7ed8882a	2026-02-11	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
SudoGest 12 Hour	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	e829aab0-3ef0-4149-8197-96c5ce0b31d2	2025-10-30	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Good Sense Suphedrine 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	1de8a7f6-e7bb-437d-8794-c4b9f43b89c9	2025-10-30	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
sinus 12 hour	PSEUDOEPHEDRINE HCL	L. Perrigo Company	26206f75-648f-47c9-8bad-25127c33961d	2025-10-03	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Sudafed Sinus Congestion 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	2025-09-15	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153 ndc (product): 50090-4629
Leader 12 Hour Sinus Nasal Decongestant	PSEUDOEPHEDRINE HCL	Cardinal Health 110, LLC. dba Leader	a647e822-c4dd-46fd-bd55-bd9226990357	2025-08-07	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Meijer Distribution Inc	4d431663-4b6a-4b00-9bbd-87d2c6b8ddad	2025-05-04	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Padagis Israel Pharmaceuticals Ltd	4a4da1e6-2ad1-47f7-a9b3-7d845962ef3b	2024-12-26	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Sudafed Sinus Congestion 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	d600b5d5-7d95-4ad6-a95b-6d73502743d7	2024-11-08	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
good neighbor pharmacy nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Amerisource Bergen	d84a0c76-ad50-4616-9252-84ca25a19ca0	2024-05-30	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Equaline 12 Hour Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	bd5c2093-f812-4dfe-80ea-68cb4e65a09c	2023-08-03	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Nasal Decongestant D	PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	9572b6c9-172b-459e-82d1-7f92f0eaec8e	2022-10-20	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
topcare 12 hour decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Topco Associates LLC	4841c79a-fb92-4209-929a-e4ea0c4015dd	2022-10-05	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
sinus pressure and congestion relief maximum strength	PSEUDOEPHEDRINE HCL	Rite Aid Corporation	aa52d998-cab8-439c-ac95-6c1f5da48ba4	2022-08-04	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
12 Hour Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	85955336-3f79-457d-822c-f8be019729d1	2019-05-23	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049154	pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	12
1049668	SUDAFED 120 MG 12HR Extended Release Oral Tablet	PSN	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	12
1049668	12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Sudafed]	SBD	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	12
1049154	12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	12
1049668	12 HR Sudafed 120 MG Extended Release Oral Tablet	SY	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	12
1049154	pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet	SY	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	12
1049668	Sudafed 120 MG 12 HR Extended Release Oral Tablet	SY	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4629-0	50090462900	1 BLISTER PACK in 1 CARTON (50090-4629-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2019-10-21	0000-00-00	No	No	Current